OVERALL ROLE OBJECTIVE
The Quality Control (QC) Validation Scientist will work in the QC Validation team to perform, develop, and validate assays which will ultimately form part of QC testing or GMP processes. This role will be integral in bridging the processes between the Product Development and QC departments by validating assays/processes to GMP standards. The post-holder will be expected to support activities across all other departments including GMP Production (cell therapy manufacture) and Clinical to ensure operational excellence and to exercise good housekeeping, high standards of cleanliness and compliance to GMP procedures in all areas.
The QC Validation Scientist will join TC BioPharm Ltd (TCB), an established cancer immunotherapy company developing cell based treatments for cancer and severe viral infections. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the QC Validation Supervisor. TCB is a fast growing, immunotherapy company developing cell-based treatments for cancer patients; moreover, our unique culture, values and working environment attracts, retains, and inspires people to give their best.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Optimisation and/or validation of flow-cytometry based assays, qPCR and ELISA.
- Performing leucocyte isolation and cell culture expansion.
- Maintenance of mammalian cell lines to include passaging and cryopreservation.
- Preparing and writing validation protocols and reports, standard operating procedures and specifications to quality and regulatory standards.
- Ensuring work is performed in accordance with the Company’s QA and Health and Safety policies including the provision of COSHH/BIOCOSHH/Risk assessments.
- Training and supervising both experienced and inexperienced members of staff.
- Reporting to the line manager/supervisor any Quality Events occurring during the manufacturing or quality control process and ensuring a report is submitted and corrective and preventative actions progressed to completion.
- Assisting the line manager/supervisor in laboratory management activities including, but not limited to, cleaning and housekeeping, ordering of reagents and consumables, maintaining calibration and servicing records, ensuring equipment compliance and ensuring a clean, organised and smooth-running working environment.
QUALIFICATIONS
- Degree level education in a biological science discipline.
SKILLS & EXPERIENCE
- Experienced in mammalian cell culture techniques.
- Practical flow cytometry, ELISA or QPCR experience.
- Experience of working in a GMP environment is desirable.
- A high level of attention to detail with a desire to continually develop and improve processes.
- A passion for science.
- The ability to work under pressure.
- Ability to work to deadlines, demonstrating flexibility and delivering results.
- Assay validation/optimisation experience will be viewed favourably
- Excellent written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational skills
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success. As we continue to expand, there will be career opportunities on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits (including private healthcare insurance, life assurance, pension, 32 days holiday) and an excellent working environment.
Laboratory-based role
Hours: 37.5 per week Monday to Friday 9am to 5pm
Some ad hoc irregular working hours may be required